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Coronavirus Vaccine Makers Are Not Mass-Slaughtering Sharks

Several companies in the race for a coronavirus vaccine have stumbled upon a new and unexpected hurdle: activists protesting the use of a substance that comes from sharks in their products.

The oily compound, called squalene, is churned out by shark livers and has immunity-boosting powers, which has led several companies to use it as an ingredient in vaccines. A group called Shark Allies has mounted a campaign calling on the Food and Drug Administration and other regulatory bodies to halt the sourcing of the compound from sharks, warning that mass distribution of a coronavirus vaccine could require harvesting tissue from more than 500,000 sharks.

The call to action made headlines around the globe. But the story on shark squalene isn’t as clear-cut as it might at first seem.

Companies commonly use squalene as a moisturizing additive in cosmetics and sunscreens. But the substance has also been occasionally used in vaccines as an adjuvant — a chemical that kick-starts the immune system into action, driving stronger, longer-lasting protection against disease.

Although adjuvants aren’t necessary for all vaccines, they can make or break certain recipes. By boosting products’ immunity-priming powers, they can also increase the immunization’s efficiency, giving the vaccine’s ingredients more bang for their buck and freeing up supplies for more doses.

Shark livers are considered among the best sources of the compound. Between 63 million and 273 million sharks die at the hands of humans each year, and liver oil is harvested from at least a couple million of them, according to Catherine Macdonald, a shark biologist in Florida.

Two of the companies under the scrutiny of Shark Allies are GlaxoSmithKline and Seqirus, which each manufacture adjuvants that contain about 10 milligrams of squalene per dose. Those ingredients are found in a number of coronavirus vaccines currently being tested in humans, including products from Sanofi, Medicago and Clover Biopharmaceuticals, which have all partnered with GSK.

According to one estimate, between 2,500 and 3,000 sharks are needed per metric ton of squalene. Shark Allies extrapolated from these statistics to arrive at their widely quoted numbers tabulating the potential ecological toll on sharks.

Such estimates are difficult to make.

Dr. Macdonald pointed out that sharks — of which there are more than 500 species worldwide — vary in size, weight and liver squalene content. The number of sharks required to yield enough squalene-adjuvanted vaccine doses to treat everyone on Earth is thus likely to be a “huge range,” she said. Her own calculations for this statistic stretch between tens of thousands and more than a million, depending on how many doses are needed per person.

It’s also the case that of the dozens of vaccine candidates in clinical trials in people, most don’t include squalene. To only rely on vaccines that use shark-based squalene, “a ton of other promising candidates would have to fail — they would have to be the last vaccines standing,” said Saad

One client in one spin studio that followed all the rules triggers a coronavirus outbreak with at least 61 cases

SPINCO, in Hamilton, Ontario, just reopened in July and had all of the right protocols in place, including screening of staff and attendees, tracking all those in attendance at each class, masking before and after classes, laundering towels and cleaning the rooms within 30 minutes of a complete class, said Dr. Elizabeth Richardson, Hamilton’s medical officer of health, in a statement.

But it still wasn’t enough.

Public health officials are very concerned about the number of cases and the size of the outbreak, especially because the city is not currently a hotspot and the facility was not ignoring health protocols, they said in a statement to CNN.

“They have also supported public health services in our investigation by sharing the messaging with all their members,” said Richardson.

There are currently 44 confirmed positive primary cases associated with SPINCO and 17 confirmed secondary cases. Exposure was linked to several classes held from September 28 to October 4.

The studio’s co-owners, Naz Zarezadegan and Ira Price, told The Hamilton Spectator on Monday that public health officials told them “patient zero displayed no symptoms.”

In a post to clients on Instagram, SPINCO exclaimed in frustration, “We took all the measures public health offered, even added a few, and still the pandemic struck us again!'”

SPINCO said it will stay closed pending further investigation by health officials.

City officials say SPINCO was operating at 50% capacity, with a 6-foot radius around each bike, and that this might raise questions about the safety of gyms and fitness studios during the pandemic.

“We continue to look at what does it mean, what do we need to understand about exercises classes,” Richardson said in a media briefing Tuesday.

Canada is reckoning with a second wave of the coronavirus which has been marked by a doubling of new, daily positive cases of Covid-19 within the past month. Targeted restrictions and closures are in place in many urban centers including Toronto and Montreal, but not in Hamilton.

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Pauses of coronavirus antibody and vaccine trials are routine, doctor says

Two setbacks have been reported in 24 hours in the fight against the coronavirus. On Tuesday, drugmaker Eli Lilly halted human testing of a COVID-19 treatment citing a potential safety concern. A person familiar with the trial told CBS News the pause will last approximately two weeks.

The treatment, which uses COVID-19 antibodies, is similar to a therapeutic given to President Donald Trump that he touted as a cure. “It was like unbelievable,” Mr. Trump said. “I felt good immediately.”

This comes as Johnson & Johnson said its vaccine trial, the largest to date, is also stopping temporarily while it investigates if an unexplained illness was caused by its vaccine.

CBS News medical contributor Dr. David Agus said these pauses are routine and reassuring.

“So this is not unusual,” Agus said. “I hope that Americans see news like this and have comfort that we are investigating every single issue with these drugs and with these vaccines to make sure they are safe for the American people.”

Thirty-seven states are seeing a rise in average new cases; only one state — South Carolina — is down. A key driver is gatherings. A recent CDC report found that a 13-year-old girl infected 11 people staying at the same house during a family vacation, without masks or social distancing.

With many Americans resisting guidelines, the death toll continues to grow. Leanna Richardson lost her mother — a third-grade teacher from North Carolina — in just 10 days.

“And if anything else, let her death be a reminder that COVID-19 doesn’t care,” Richardson said. “COVID-19 is serious. This is a pandemic. This is not a joke.”

School officials at her mother’s school said they do not believe she contracted the virus at work where she was teaching students in person. 

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Virginia governor critical of Trump’s coronavirus response in first appearance since testing positive

About 65 staff members who had close contact with the Northams were told to ­self-isolate for two weeks. Northam said none tested positive, which he called “a testament” to the value of wearing masks.

He noted that masks protected several staff members who could not physically distance from him before he tested positive, including a press secretary, photographer and security detail who traveled in an SUV and airplane with Northam.

He contrasted that with the largely mask-free Rose Garden ceremony last month that Anthony S. Fauci, the nation’s top infectious-disease expert, has called a superspreader event. Trump, first lady Melania Trump and several others subsequently tested positive for the virus.

“No masks, no social distancing — and look at the number of people that tested positive,” Northam said Tuesday, referring to the White House event. “We talk about science, it doesn’t get any clearer than that . . . I would remind every Virginian: Masks are scientifically proven to reduce the spread of this disease, plain and simple.”

Northam, a former Army doctor and pediatrician, said his and his wife’s symptoms were mild. He warned Virginians not to let down their guard, particularly as cooler fall temperatures and shrinking daylight hours make outdoor socializing less appealing.

The governor said he is unlikely to ease pandemic-related restrictions in the near term. He acknowledged pressure to return to in-person education at public schools but urged continued caution.

“Numbers are going up in a number of states across this country, so we’re not out of the woods,” he said. “We’re nowhere close to being out of the woods.”

The greater Washington region on Tuesday reported 1,763 additional coronavirus cases and 20 deaths. Virginia added 1,235 cases and 11 deaths, Maryland added 482 cases and nine deaths, and the District added 46 cases and no deaths.

Virginia’s daily caseload was above its rolling seven-day average, lifting that number to 1,089 — the state’s highest daily average since Aug. 13.

The seven-day average in Northern Virginia rose Tuesday to 264 cases, a four-month high in the region.

Daily caseloads Tuesday in Maryland and the District were below their rolling seven-day averages. It’s the third consecutive day that both jurisdictions reported new infections at or below their recent average amid an uptick that began earlier this month.

The recent caseload rise across the region has coincided with the outbreak at the White House, although local health officials have said it’s unclear whether there’s a connection.

Dana Hedgpeth contributed to this report.

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J&J says review of illness that led to pause of coronavirus vaccine trial could take days

(Reuters) – Johnson & Johnson said on Tuesday it would take a few days at least to hear from a safety monitoring panel about its review of the company’s late-stage COVID-19 vaccine trial after announcing that the large study had been paused due to an unexplained illness in one participant.

The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill. That trial remains on pause.

U.S.-based J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the U.S. Food and Drug administration before the study can be restarted.

Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.

“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.

He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo.

J&J said such pauses are normal in big trials, which can include tens of thousands of people. The company said the trial is still on track to continue adding patients over the coming months.

It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.

Former FDA chief said on Twitter the trial said that the oversight of safety boards for the COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.

Experts and officials have voiced concerns that U.S. President Donald Trump could put pressure on vaccine makers to rush an unsafe or ineffective vaccine to market.

AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant.

While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.

The J&J and AstraZeneca vaccines both use modified, harmless versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.

FILE PHOTO: The company logo for Johnson & Johnson is displayed to celebrate the 75th anniversary of the company’s listing at the New York Stock Exchange (NYSE) in New York, U.S., September 17, 2019. REUTERS/Brendan McDermid/File Photo

They are both also

Black Doctors Work to Make Coronavirus Testing More Equitable

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

When the coronavirus arrived in Philadelphia in March, Dr. Ala Stanford hunkered down at home with her husband and kids. A pediatric surgeon with a private practice, she has staff privileges at a few suburban Philadelphia hospitals. For weeks, most of her usual procedures and patient visits were canceled. So she found herself, like a lot of people, spending the days in her pajamas, glued to the TV.

And then, at the beginning of April, she started seeing media reports indicating that Black people were contracting the coronavirus and dying from COVID-19 at greater rates than other demographic groups.

“It just hit me like, what is going on?” said Stanford.

At the same time, she started hearing from Black friends who couldn’t get tested because they didn’t have a doctor’s referral or didn’t meet the testing criteria. In April, there were shortages of coronavirus tests in numerous locations across the country, but Stanford decided to call around to the hospitals where she works to learn more about why people were being turned away.

One explanation she heard was that a doctor had to sign on to be the “physician of record” for anyone seeking a test. In a siloed health system, it could be complicated to sort out the logistics of who would communicate test results to patients. And, in an effort to protect health care workers from being exposed to the virus, some test sites wouldn’t let people without cars simply walk up to the test site.

Stanford knew African Americans were less likely to have primary care physicians than white Americans, and more likely to rely on public transportation. She just couldn’t square all that with the disproportionate infection rates for Black people she was seeing on the news.

“All these reasons in my mind were barriers and excuses,” she said. “And, in essence, I decided in that moment we were going to test the city of Philadelphia.”



Dr Ala Stanford and her staff on duty a coronavirus testing site in Pennsylvania. Stanford created the Black Doctors COVID-19 Consortium and sends mobile test units into neighborhoods.

Black Philadelphians contract the coronavirus at a rate nearly twice that of their white counterparts. They also are more likely to have severe cases of the virus: African Americans make up 44% of Philadelphians but 55% of those hospitalized for COVID-19.

Black Philadelphians are more likely to work jobs that can’t be performed at home, putting them at a greater risk of exposure. In the city’s jails, sanitation and transportation departments, workers are predominantly Black, and as the pandemic progressed they contracted COVID-19 at high rates.

The increased severity of illness among African Americans may also be due in part to underlying health conditions more prevalent among Black people, but Stanford maintains that unequal access to health care is the greatest driver of the disparity.

“When an elderly funeral home director in West Philly tries to get tested

Johnson & Johnson pauses coronavirus vaccine trial following ‘unexplained illness’ in participant

Pharmaceutical giant Johnson & Johnson on Monday night announced that it had paused its late-stage COVID-19 vaccine trial after an “unexplained illness” was reported in a participant. 

“Adverse events – illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies,” the company said in a statement when announcing the temporary halt. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 

The pause, which was first reported by the health news site STAT, come after the company began the Phase 3 trial of its vaccine in September. 
(iStock)

No details on the illness were revealed, and it’s not currently clear if the illness is related to the shot or was a coincidence. It’s also not clear if the volunteer had received the vaccine or the placebo. 

“Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company added. 

CLOTH CORONAVIRUS FACE MASKS WORK — BUT ONLY IF YOU DO THIS AFTER WEARING THEM, STUDY FINDS

The pause, which was first reported by the health news site STAT, comes after the company began the Phase 3 trial of its vaccine in September. 

The temporary halt is not the first to occur in the race to find a safe and effective vaccine to protect against COVID-19. In fact, the pause is the second such hold to occur among several vaccine candidates that have reached large-scale final tests in the U.S.

RISKIEST BEHAVIORS TO AVOID DURING CORONAVIRUS PANDEMIC, ACCORDING TO AN EXPERT

Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the U.S. as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company’s testing has restarted elsewhere.

Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the U.S. require two shots.

CLICK FOR COMPLETE CORONAVIRUS COVERAGE 

The Associated Press contributed to this report. 

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Dutch PM Orders ‘Partial Lockdown’ To Halt Coronavirus Surge

The Netherlands will go into “partial lockdown” to curb one of Europe’s biggest coronavirus surges, with all bars, cafes and restaurants to close, Dutch Prime Minister Mark Rutte said Tuesday.

The sale of alcohol and cannabis will also be banned after 8pm (1800 GMT) in a bid to reduce the social contacts that have led to the rise in Covid-19 cases, Rutte said of the steps.

After long refusing to make the wearing of masks compulsory, Rutte finally ordered that non-medical face coverings must also be worn in all indoor spaces by people aged over 13.

“We are going into a partial lockdown. It hurts but it’s the only way, we have to be stricter,” Rutte told a televised press conference.

“If we do all of this, we can quickly return to a more normal life.”

The rules will take effect at 10pm (2000 GMT) Wednesday and will last for an initial period of two weeks, when the government will review whether they have halted the spread of the virus.

The Dutch government for months opted for what Rutte called an “intelligent lockdown” policy that was far more relaxed than its European neighbours.

But it has scrambled to control the second wave of the disease.

The Netherlands currently has the third highest rate of new infections per 100,000 people in Europe over the last 14 days, behind only the Czech Republic and Belgium, according to the European Centre for Disease Prevention and Control.

After long refusing to make the wearing of masks compulsory, Dutch Prime Minister Mark Rutte finally ordered that non-medical face coverings must also be worn in all indoor spaces by people aged over 13 After long refusing to make the wearing of masks compulsory, Dutch Prime Minister Mark Rutte finally ordered that non-medical face coverings must also be worn in all indoor spaces by people aged over 13 Photo: ANP / Bart Maat

Dutch health authorities on Wednesday reported a daily record of 7,393 new coronavirus infections, with 43,903 new cases over the past week and 150 deaths.

Among the new measures, team sports for over 18s are banned, while people are now limited to having three visitors at their home per day.

The new steps largely target the catering and entertainments industry where the government says the disease is spreading.

Restaurants and cafes will close for everything except takeaway, as will the Netherlands’ famous “coffee shops” that sell cannabis.

“No more alcohol or soft drugs will be sold or delivered between 8:00pm and 7:00am,” the government’s new regulations say, while public consumption of either is also banned during those hours.

The Netherlands has also lagged behind other European countries in ordering the wearing of masks, but Rutte said he wanted to “settle a lingering discussion once and for all”.

The Dutch government gave “urgent advice” to wear masks in its last set of measures two weeks ago, but “that did not provide sufficient clarity” and many people continued to go without them, said Rutte.

Rutte, who marks ten years in power on Wednesday, has faced growing criticism over the government’s failure to rein in coronavirus cases.

Populist opposition parties in particular have been using the Covid-19 crisis to push their

U.S. pauses Eli Lilly’s trial of a coronavirus antibody treatment over safety concerns

  • Eli Lilly’s phase-three trial of its ACTIV-3 monoclonal antibody treatment for coronavirus has been paused due to potential safety concerns.
  • The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an anti-viral with emergency use authorization for the virus.
  • It’s one of several ongoing trials, as part of the National Institute of Health’s “Activ” program, designed to accelerate the development of vaccine treatments in partnership with the pharmaceutical industry.



a group of people standing around a plane: In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.


© Provided by CNBC
In this May 2020 photo provided by Eli Lilly, researchers prepare mammalian cells to produce possible COVID-19 antibodies for testing in a laboratory in Indianapolis.

Eli Lilly’s late-stage trial of its leading monoclonal antibody treatment for the coronavirus has been paused by U.S. health regulators over potential safety concerns, the company confirmed to CNBC on Tuesday.

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“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” a spokeswoman Molly McCully told CNBC. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The company’s shares fell by about 3% in afternoon trading after the news started to leak out over Twitter.

The news comes less than 24 hours after Johnson & Johnson confirmed that its late-stage coronavirus vaccine trial was paused after a participant reported an “adverse event” the day before.

Dr. Mathai Mammen, global head of Janssen research and development at J&J, told investors on a conference call Tuesday that the company still has “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. Preliminary information has been sent to the data safety monitoring board for review, he added.

Medical experts note that pauses in large clinical trials are not uncommon. They added it’s possible the bad reaction could be result of an unrelated illness, and not the drug itself. The review from the data and safety monitoring board will help determine that.

The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with Gilead Sciences’ remdesivir, an anti-viral with emergency use authorization for the virus. It’s one of several ongoing trials that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of Covid-19 vaccines and treatments. It is also backed by Operation Warp Speed, the Trump administration’s effort to manufacturer and distribute vaccines to fight Covid-19.

Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight the virus. The treatment was developed using a blood sample from one of the first U.S. patients who recovered from Covid-19. AstraZeneca and Regeneron, among other companies, are also working on so-called antibody treatments.

Monoclonal antibody treatments hit the headlines this month after news broke

Coronavirus Outbreak ‘Likely’ To Get Worse In Ohio, Governor Says

COLUMBUS, OH — A somber Gov. Mike DeWine said Ohio faces a difficult stretch in its battle with the coronavirus.

“Things will get better…but in all likelihood things will get worse before they get better,” DeWine said. “The virus is tough. It is cunning. It almost has a mind of its own.”

The governor expressed his confidence in a forthcoming vaccine, but urged Ohioans to don masks and follow health guidance. DeWine wants more compliance with mask guidelines from Ohioans, preferably with at least 85 percent of Ohioans wearing masks in public.

Don’t miss the latest updates from health and government officials in Ohio on the coronavirus. Sign up for Patch newsletters and news alerts.

To keep the economy fluttering with life, Ohioans will need to wear masks, DeWine said. To keep the state’s remaining institutions open and functioning, including schools and sports, Ohioans must also follow social distancing guidelines.

“Wear masks when you are in any place where you will see others. The virus wants us to get complacent because it needs us to spread it,” DeWine said.

The governor said the vigilance and sacrifices of Ohioans has kept the state’s COVID-19 outbreak from hitting cataclysmic proportions and has prevented largescale outbreaks. However, the virus has been spreading rapidly across the Buckeye State.

DeWine highlighted Ohio’s surge in new cases and rising positivity rates on COVID-19 tests. Two weeks ago, Ohio was confirming approximately 1,000 new cases per day. Over the past seven days, Ohio has averaged 1,400 new cases per day.

Other early indicators of COVID-19 spead have been spiking, DeWine said. Visits to medical offices, people reporting COVID-19-like symptoms and other metrics have been jumping rapidly.

“This shows just how this virus has spread throughout the state,” DeWine said.

Here are all of Tuesday’s COVID-19 numbers in Ohio:

More reading:

This article originally appeared on the Across Ohio Patch

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